Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs

October 18, 2012 updated by: Corrie Myburgh, University of Southern Denmark

Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Upper Trapezius Myofascial Trigger Points- a Randomized Intervention Study

In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Funen
      • Odense, Funen, Denmark, 5230
        • Univ. of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 46 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • A clinically relevant MFTrP of the upper Trapezius musculature
  • Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).
  • BMI less than 31

Exclusion Criteria:

  • a history of chronic, systemic pathology (e.g. hemophilia)
  • pre-existing neck/shoulder pathology/surgical procedures,
  • clinical depression
  • health-related legal action
  • pregnant
  • anti-inflammatory and/or chronic pain medication
  • had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dry needling (deep)
Subjects receive dry needle insertion deeper than 1,5cm below the skin of the Trapezius.
Procedure: Dry needling
Insertion of acupuncture needle into a myofascial trigger point.
Other Names:
  • Acupuncture
ACTIVE_COMPARATOR: Dry needling (superficial)
Insertion of dry needle less than 1cm.
Procedure: Dry needling
Insertion of acupuncture needle into a myofascial trigger point.
Other Names:
  • Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle contractility
Time Frame: 30 minutes
Measurements of maximal isometric muscle force (Fmax), and rate of force development (RDF)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pressure-pain threshold
Time Frame: 60 seconds
Algometer measurement of pressure-pain perception
60 seconds
NRS-101
Time Frame: 60 seconds
Self-reported pain
60 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Lundbeck Foundation
IMK Almene Fond
Dansk Kiropraktor Fond

Investigators

  • Study Director: Jan Hartvigsen Hartvigsen, PhD, Univ. of Southern Denmark
  • Study Director: Per Aagaard, PhD, Univ. of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (ESTIMATE)

October 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 19, 2012

Last Update Submitted That Met QC Criteria

October 18, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Muscle and needling

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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